FDA Accepts BLA for Linvoseltamab in Relapsed or Refractory MM

The US Food and Drug Administration (FDA) has accepted for Priority Review a Biologics License Application (BLA) for linvoseltamab for adult patients with relapsed or refractory multiple myeloma (MM) that has progressed after at least three prior therapies, according to a press release from Regeneron Pharmaceuticals, the manufacturer of the drug.

The target action date for the FDA’s decision is August 22, 2024. In early February 2024, The European Medicines Agency accepted a Marketing Authorization Application for linvoseltamab for review.

The BLA is supported by data from the ongoing phase I/II LINKER-MM1 trial. The phase I dose escalation portion of the trial assessed the safety, tolerability, and dose-limiting toxicities across nine dose levels of linvoseltamab, exploring either intravenous or subcutaneous administration regimens.

The phase II dose expansion portion is currently assessing the safety and antitumor activity of linvoseltamab, with objective response rate as the primary endpoint.

A phase III confirmatory trial is currently enrolling.